生命科学
生命科学 解决方案 and 服务
你如何衡量成功? 在生命科学行业, 成功取决于质量, 验证, 法规遵从性, 产品安全, 效率和盈利能力. Insufficient control and bottlenecks, however, can negatively impact your manufacturing processes. System enhancements can improve your profitability, but only if you avoid setbacks related to overtaxed resources, schedule slippage and unrealistic project estimates. 过程分析技术(帕特) practices have made improvements easier to implement, but once a process is working and validated, the steps involved with changes are complex. Forward-thinking companies who are proactive and rise to meet these and other challenges will benefit in the short term. The ability to improve processes and embrace smart manufacturing technology, even in a regulated and validated environment, is key to sustainability and future success.
特立独行的 Technologies identifies key operations and improves performance for greater safety, efficiency and overall profitability. 我们提供生物技术, pharmaceutical and medical device manufacturing 咨询 and can work with you to implement the right solutions that support your process, helping you produce your drug and device products 更好的. 例如, we can help you maximize throughput, improve asset reliability and ensure quality and 法规遵从性.
我们所有的解都符合21 病死率 第11部分的要求， 大伞 V模型与 ASTM standards for a range of capabilities, and we can deliver the full benefits of 帕特, Factories of the Future including single use technology (SUT), and serialization concepts to reduce cost per drug. 凭借我们丰富的专业知识, we can support your team and provide a complete business perspective — making improvements from the plant floor to the boardroom to optimize performance at every level.
特立独行的’s customers in the life sciences and biotech industries have benefited from our industrial automation, 企业集成, 系统迁移, 咨询, commissioning and sustaining services. Leveraging our unique enterprise-wide perspective, we encompass all areas of biotech and life science manufacturing processes and equipment, including bioreactors and fermentation systems, 媒体的准备, 喷雾干燥器, 离心机, 净化(色谱法, Uf / df), 产品有效成分, 填充和完成, 冻干, clean-in-place, steam-in-place and water for injection.
解决方案 for Improved Profitability
Partner with 特立独行的 to benefit from our unique offering, categorized into four different types of project phases:
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1
业务和技术分析
制定范围定义, 估计, 风险评估, 供应商和生命周期分析, 选择, schedule and financial plan / justification.
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2
Project Execution and 实现
制定项目规范, 详细设计工程, 组态和编程, 采购, 部署, 安装, schedule and risk management as well as all documentation and good manufacturing practice (GMP) 验证 life cycle steps.
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3
Checkout, Commissioning and Startup
提供项目支持, 包括循环检查, 动态测试, 培训, turnover documentation and GMP 验证 life cycle steps.
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4
持续支援服务
maintain project gains once the project has been fully commissioned, 包括预防性维护, 仪器校正及维修, software maintenance and configuration support, 网络安全, corrective and preventative actions.
Have a 生命科学 Industry Expert Contact You
其他服务包括:
- A specially assembled team of trained, certified professionals with the skills needed to deliver life sciences solutions in the country where you work
- Capabilities in enterprise-wide services, from automation to business-level IT solutions
- Deep expertise and knowledge of best practices for the life sciences industry
- Knowledge of best practices gained from working in related industries, such as consumer-packaged goods and food and beverage
- Expertise in laboratory information management systems.
- A track record of adhering to budgets and timelines
- Platform-independent, scalable solutions that utilize your existing infrastructure
- 已证实项目完成® methodology for meeting critical objectives with consistency and repeatability
- The OpCon Advantage, combining the right people, process and technology to ensure project success
- Data enablement, bring data to life from clinical trial to full-blown manufacturing
- Batch solutions that provide S88 flexibility
- Turnkey solutions and main automation contractor (MAC) capabilities
- Building and Environmental Automation Systems